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AndroGel and Heart Attack Risk

AndroGel and Heart Attack Risk

AndroGel, prescribed as a drug meant to replace testosterone, is one of the most used medical products for treating low testosterone in the U.S., and is mostly prescribed to men whose bodies fail to produce sufficient amounts of the hormone. Approved by the U.S. Food and Drug Administration (FDA) in 2011, it was developed by Solvay Pharmaceuticals, a Brussels, Belgium-based pharmaceutical company.

Made in the U.S. by AbbVie Inc., it was heavily marketed after their parent company, Abbott Laboratories, purchased the drug from Solvay Pharmaceuticals in 2010. AbbVie reportedly spent $80 million on marketing campaigns in 2012 alone, and the gel generated more than $1 billion in sales that year. It is the top-selling testosterone replacement therapy in the U.S. marketed by AbbVie Inc., but by no means does that make it risk-free. Within the first two years of its release, doctors began raising concerns about dangerous side effects associated with older users.

A study published in 2014 found that older men, and younger men with pre-existing heart disease, had a “substantially increased” risk of heart attacks after using testosterone replacement therapy. Five men, whose ages range from 50 to 63, filed a lawsuit in the U.S. District Court for the Northern District of Illinois against Abbott Laboratories and AbbVie Inc., claiming that the companies hid the dangerous side effects of using AndroGel. Two of the men suffered strokes, and the other three suffered heart attacks.

The lawsuit was filed only four days after the FDA announced that it would re-examine the safety of testosterone replacement therapy after several studies showed that they caused a higher risk of heart attacks and strokes in men using the products. As of April 2014, there were several dozen pending federal lawsuits against Abbott Laboratories and AbbVie Inc. claiming that the drug manufacturers failed to provide sufficient warning about the health risks from using AndroGel, including heart attack, stroke, deep vein thrombosis, and pulmonary embolism.

AndroGel already had a black box warning for secondary exposure to women and children. It states that women and children should avoid contact with unwashed clothing or application sites of men using the drug. Side effects caused by secondary exposure include:

  • Advanced bone age in children
  • Aggressive behavior
  • Early development of pubic hair in children
  • Enlargement of the genitals
  • Increased erections
  • Increase in acne and body hair in women
  • Increased libido

Along with those listed side effects and the suspected cardiovascular risks, AndroGel may also cause other negative side effects, including:

  • Edema
  • Gynecomastia
  • High cholesterol
  • Larger red blood cells
  • Prostate cancer
  • Reduced sperm count
  • Sleep apnea

If you or a loved one took AndroGel and suffered from a heart attack, stroke, or other related effect, you may be entitled to compensation. Contact Domina Law Group today for a case evaluation, or call us at 888-387-4134 to set up a meeting.

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